Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet

A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01443208

Enrollment

Registered

2011-09-29

Start date

2011-11-30

Completion date

2011-12-31

Last updated

2012-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects

Brief summary

To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

Interventions

DRUGdesvenlafaxine

one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects * Between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion criteria

* Elevated risk of suicide, in the opinion of the investigator or expert consultant * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Design outcomes

Primary

Measure	Time frame
For single dose: maximum concentration (Cmax)	day 1
For single dose: time to first occurence of Cmax (Tmax)	day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)	day 1
For multiple dose: maximum concentration (Cmax)	day 8
For multiple dose: time to first occurence of Cmax (Tmax)	day 8
For multiple dose: trough concentration (Ctrough)	day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)	day 8

Secondary

Measure	Time frame
For single dose if data permit: terminal elimination half life (t1/2)	day 1
For multiple dose if data permit: apparent volume of distribution (Vz/F)	day 8
For single dose if data permit: area under curve (0-infinity) (AUCinf)	day 1
For single dose if data permit: oral clearance (CL/F)	day 1
For single dose if data permit: apparent volume of distribution (Vz/F)	day 1
For multiple dose if data permit: accumulation factor (Rac)	day 8
For multiple dose if data permit: terminal elimination half life (t1/2)	day 8
For multiple dose if data permit: oral clearance (CL/F)	day 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026